← Product Code LFL · K032066

# SONOSURG SYSTEM (K032066)

_The Olympus Optical Co. · LFL · Oct 3, 2003 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K032066

## Device Facts

- **Applicant:** The Olympus Optical Co.
- **Product Code:** LFL
- **Decision Date:** Oct 3, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended Use

The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-T2L-GE, SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.

## Device Story

The Olympus SonoSurg System is an ultrasonic surgical instrument platform used for tissue management. It comprises a generator, irrigation unit, transducers, and various surgical instruments/suction devices. The system utilizes ultrasonic energy to dissect, fragment, and emulsify tissue, while simultaneously aspirating the material. It is intended for use in clinical settings by surgeons during general, laparoscopic, plastic/reconstructive, and urological procedures. The system can be integrated with Olympus electrosurgical units (UES-20/UES-30) to provide combined ultrasonic and electrosurgical capabilities. The surgeon operates the handpiece to perform tissue manipulation, with the system providing controlled mechanical fragmentation and suction to facilitate surgical access and tissue removal. The device benefits patients by enabling precise tissue resection and aspiration during minimally invasive and open surgical procedures.

## Clinical Evidence

Bench testing only. No clinical data was required for the evaluation of safety and efficacy as the device does not incorporate significant changes in intended use, method of operation, material, or design compared to the predicate devices.

## Technological Characteristics

System includes generator, irrigation unit, transducers, and ultrasonic instruments. Patient-contacting materials are identical to previously cleared devices and confirmed per ISO 10993-1. Operates via ultrasonic energy for tissue fragmentation/aspiration. Meets IEC 60601-1, IEC 60601-1-1, and IEC 60601-2-2 safety standards. Compatible with external electrosurgical units.

## Predicate Devices

- Olympus Ultrasonic Surgical System ([K021962](/device/K021962.md))
- CUSA Excel Ultrasonic Surgical Aspirator System ([K981262](/device/K981262.md))
- SONOPET UST-2001 Ultra Surgical Aspirator ([K010309](/device/K010309.md))
- Ultrasonic Surgical System ([K962952](/device/K962952.md))

## Submission Summary (Full Text)

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K 032066

OCT - 3 2003

# SMDA 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.

## A. GENERAL INFORMATION

## 1. Applicant

| Name & Address:      | Aomori Olympus Co., Ltd. 2-248-1 Okkonoki Kuroishi-shi, Aomori-ken, Japan 036-0357 |
|----------------------|------------------------------------------------------------------------------------|
| Registration Number: | 9614641                                                                            |

2. Initial Importer

| Name & Address:      | Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-3157 |
|----------------------|--------------------------------------------------------------------------|
| Registration Number: | 2429304                                                                  |

3. Submission Correspondence

| Name, Address, Tel & Fax, Contact: | Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-3157 TEL 631-844-5477 FAX 631-844-5416 Tina Steffanie-Oak, Senior RA Analyst |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number:               | 2429304                                                                                                                                          |

## B. DEVICE IDENTIFICATION

# 1. Common/Usual Name

Surgical System

## 2. Device Name

Olympus SonoSurg System

### 3. Classification Name

| CFR Number      | Classification Name            | Class | Product Code |
|-----------------|--------------------------------|-------|--------------|
| Not established | Ultrasonic Surgical Instrument | II    | LFL          |

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## C. IDENTIFICATION OF LEGALLY MARKETED DEVICES WHICH WE CLAIM SUBSTANTIAL EQUIVALENCE

| Model                                              | 510(k)#  | Manufacturer              | Class | Product<br>Code |
|----------------------------------------------------|----------|---------------------------|-------|-----------------|
| Olympus Ultrasonic<br>Surgical System              | #K021962 | Olympus                   | II    | LFL             |
| CUSA Excel Ultrasonic<br>Surgical Aspirator System | #K981262 | Valleylab                 | II    | LFL             |
| SONOPET UST-2001 Ultra<br>Surgical Aspirator       | #K010309 | Miwatec                   | II    | LFL             |
| Ultrasonic Surgical System                         | #K962952 | Olympus Optical Co., Ltd. | II    | LBK             |

Please see abbreviated comparison table of SonoSurg System and Predicate Devices.

### D. DEVICE DESCRIPTION

#### 1. Summary

In conclusion, the subject device is substantially equivalent to the predicate devices. A comparison table of the subject device and predicate devices is found in Attachment 2-A.

#### 2. Design

The Olympus SonoSura System has been designed and tested in compliance with voluntary safety standards. It meets the requirement of IEC 60601-1, IEC 60601-1-1 and IEC 60601-2-2.

#### 3. Materials

All the patient contacting materials used in this system are identical materials that have been cleared in the past 510(k) submissions. All materials have been confirmed with ISO 10993-1.

#### 3. Intended Use of the device

The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-T2L-GE, SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.

#### 5. Summary including conclusion drawn from Non-clinical Tests

When compared to the Olympus Ultrasonic Surgical System(#K021962), CUSA EXcel Ultrasonic Surgical Aspirator System(#K981262), SONOPET UST-2001 Ultra Surgical Aspirator(#K010309) and Ultrasonic Surgical System(#K962952), the Olympus Surgical System does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect safety and effectiveness. Therefore clinical data is not necessary for its evaluation of safety and efficacy.

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EPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

OCT - 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Olympus Optical Company c/o Ms. Tina Steffanie-Oak Associate Manager, Regulatory Affairs/Clinical Monitor Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157

Re: K032066

Trade/Device Name: Olympus SonoSurg System Regulatory Class: Unclassified Product Code: LFL Dated: July 3, 2003 Received: July 7, 2003

Dear Ms. Steffanie-Oak:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Tina Steffanie-Oak

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark A Milham

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

## 510(k) Number (if known): K032066 Device Name: Olympus SonoSurg System

## Indications for Use :

The Olympus SonoSurg System consists of the SonoSurg Generator (SonoSurg-G2 Set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducers (SonoSurg-T2L-GE, SonoSurg-T2L-GE-C), and SonoSurg ultrasonic surgical instruments and surgical suction devices (T3000 Series). This system is intended to dissect, fragment, emulsify, and aspirate tissue for General Surgery, Laparoscopic Surgery, Plastic and Reconstructive Surgery, and Urological Surgery. This system may also be combined with electrosurgery using Olympus Model UES-20 or UES-30 Electrosurgical Units.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Prescription 21 CFR 801.109)

ાર

Over-The-Counter Use

(Prescription 21 CFR 801.109)

Mark N. Millerson
(Optional Format 1-2-96)
(Division Sign Off)

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Cheral, Restorative and Neurological Devices

510(k) Number K032066

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**Source:** [https://fda.innolitics.com/device/K032066](https://fda.innolitics.com/device/K032066)

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